BEUDAMED
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    WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR

    FDA 510(k)
    FDA Class 2 ·Dental

    PowerPICC Provena

    FDA UDI
    Bard Access Systems, Inc.·00801741141775·Catheter Placement Kit

    FlowLogic Assert

    FDA UDI
    SONENDO, INC.·00810209420772·FlowLogic Assert Shaping File 30/.06, 31mm

    COMPUMEDICS E-SERIES EEG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNK

    FDA Adverse Event
    Injury ·APPLIED MEDICAL RESOURCES·Product code GEI·April 4, 2022

    UNK

    FDA Adverse Event
    Injury ·APPLIED MEDICAL RESOURCES·Product code GEI·April 4, 2022

    SM104 M-SERIES W/5TH WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 12, 2013

    QUATTRODE LEAD, 3/6MM, 90 CM

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·February 17, 2011

    AGILIS NXT, 8.5F. STEERABLE INTRODUCER, SMALL CURL

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL·Product code DYB·February 21, 2008

    CARDIOSAVE

    FDA Adverse Event
    Injury ·DATASCOPE CORP.·Product code DSP·April 17, 2014

    CARDIOSAVE HYBRID, TYPE G PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·April 18, 2024

    CARDIOSAVE HYBRID, TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·November 2, 2021

    qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by 2 Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECU, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open windows and display information on other networked monitors. The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 28, 2012

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012